FDA approves a new subcutaneous formulation of Johnson & Johnsons lung cancer drug amivantamab, allowing the therapy to be administered in minutes rat...
Regulators place a clinical hold on a pivotal lung cancer trial of ifinatamab deruxtecan after reports of treatment-related deaths from lung toxicity,...
House and Senate Democratic health leaders ask AstraZeneca, Lilly, Novo Nordisk, and Pfizer for details about the drug pricing deals the companies mad...
FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations after investigators fo...
Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hormone equilin that is...
Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues with information tha...
FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.
FDA denies an Akebia Therapeutics 2019 petition for reconsideration seeking five-year new chemical entity exclusivity for its Auryxia.
